Regulatory Affairs Specialist

4 days ago


Riyadh, Saudi Arabia Takeda Pharmaceutical Full time

**Job Purpose**

Responsible for the regulatory affairs procedures for Saudi Arabia and assigned therapeutic area.

**Primary duties**

Responsible to prepare and execute optimal regulatory strategies aimed to deliver product approvals and/or life cycle management in accordance with the regulatory objectives of the regional business.

Develop effective relationships with local commercial organization, distributors and service providers if needed

Ensure compliance with local regulation as part of Responsible pharmacist duties in front of KSA authorities

Provide regulatory guidance and advice on local country regulatory environments.

Provide assessment of the impact of new and changing regulations/requirements in KSA countries

Use external resources to assist with the above tasks to not only meet timelines but expediting the time to market.

**Responsibilities**

Regulatory Affairs:
% of Time/ Job Function and Description
- 60%

In collaboration with Global RA, provide regulatory strategies to responsible functional groups and regulatory management.

Prepare and maintain project plans and timelines of approvals and planned submissions.

Ensure that Takeda’s products comply with the registration of health authorities in KSA

Ensure appropriate evaluation of local business and regulatory registration requirements for investigational and marketed products and prepare regulatory assessment reports as needed.

Interact with distributors; service providers and regulatory agencies to resolve related review questions

Act as a point of contact for the assigned projects and as interface with key corporate functional areas
- 20%

Ensure compliance of regulatory activities in Saudi Arabia consistent with Country laws and Takeda’s internal protocols and procedures

Ensure compliance with Saudi FDA local regulation

Ensure regional regulatory documents, record keeping in secure, comprehensive manner

Ensure that all local product information used locally are up to date
- 10%

Provide guidance/advice on international regulatory environments, provide assessment of the impact of new and changing regulations/requirements

Develop effective working relationships with business partners and service providers in the KSA
- 10%

Support the RA Head the ME on specific projects as requested in alignment with RA Lead Saudi Arabia.

**Major Challenges**
- To comply with different requirements of products registration in Saudi Arabia.
- Ensure uniformity and alignment of cluster/regional strategies, processes, and policies.
- Proper utilization of resources to effectively implement the registration strategies.

**Key Decisions Expected**
- Finalization of new products registration as per plan
- Execution of KSA Regulatory affairs strategies to achieve business objectives
- External interface with health authorities and Takeda distributors
- Day to day operational decisions

**Dimensions**
- Geographical span: Saudi Arabia

**Skills & knowledge**

**Educational qualifications**

BA in related field from a renowned institution / university Saudi National & Pharmacist

**Relevant Experience & knowledge**
- 4-5 years of total experience
- 3+ years of solid Regulatory affairs experience in a medium to large size reputable organization/s in Saudi Arabia
- Good in-depth knowledge of key business functions such as Sales, business development, marketing, Medical, etc.
- In-depth understanding of pharmaceutical industry within the country
- Applicant must be a Saudi National

**Personal Characteristics & behaviors**
- Strategic thinker, innovative, able to drive multiple simultaneous initiatives, able to work under pressure
- Must be able to work in a fast-paced environment with demonstrated ability to deal with competing tasks and demands.
- Excellent verbal and written communication skills
- Goal oriented, focused, energetic, and enthusiastic
- IT savvy and process orientation
- Excellent team work and collaboration

**Locations**:
Riyadh, Saudi Arabia

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time



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